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New treatment option for Heart Failure With Reduced Ejection Fraction (HFrEF)
Official title Telemedicine-guided Uptitration of Therapy in Chronic Heart Failure
ClinicalTrials.gov ID: NCT07518030
What this study is testing
- What it's testing
- This is a single-center, randomized, open-label, no-profit interventional trial designed to evaluate the effectiveness of a telemedicine-based follow-up strategy compared with standard ambulatory care in patients with newly diagnosed heart failure with reduced ejection fraction (HFrEF). The study aims to determine whether telemedicine-guided management improves the optimization of guideline-directed medical therapy (GDMT), measured as change in GDMT score at 6 months.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must meet all of the following criteria:
- Provision of written informed consent.
- Age ≥18 years.
- Recent diagnosis of HFrEF, defined according to ESC criteria, established in either an inpatient or outpatient setting.
- No prior initiation of GDMT for HF at the time of enrollment, or treatment limited to a single agent with potential disease-modifying effects...
You likely can't join if
- Ongoing treatment with two or more guideline-directed heart failure medications at the time of HFrEF diagnosis
- Presence of severe comorbidities or clinical instability requiring prolonged or continuous hospital management
- Estimated life expectancy \<12 months
- Pregnancy or breastfeeding
See the full eligibility criteria
- Participants must meet all of the following criteria:
- Provision of written informed consent.
- Age ≥18 years.
- Recent diagnosis of HFrEF, defined according to ESC criteria, established in either an inpatient or outpatient setting.
- No prior initiation of GDMT for HF at the time of enrollment, or treatment limited to a single agent with potential disease-modifying effects prescribed for a different clinical indication.
- Availability of adequate digital literacy, either by the patient or a caregiver, defined as the ability to use electronic devices for remote communication (phone/video calls), transmission of vital parameters (body...
- Any etiology of HF is eligible, including ischemic, valvular, primary or infiltrative cardiomyopathies, iatrogenic or toxic causes, and tachycardia-induced cardiomyopathy.
- Ongoing treatment with two or more guideline-directed heart failure medications at the time of HFrEF diagnosis
- Presence of severe comorbidities or clinical instability requiring prolonged or continuous hospital management
- Estimated life expectancy \<12 months
- Pregnancy or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Piacenza, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Piacenza, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.